What’s Ahead: This Week

 Hearings/Markups –

  • Tuesday, July 31
    • Senate HELP Committee, “Reducing Health Care Costs: Decreasing Administrative Spending.”
  • Wednesday, August 1
    • Senate Veterans Affairs Committee, “Hearing on Pending Legislation.”

 Notable Policy Events –

  • Tuesday, July 31
    • Hudson Institute, “Innovating Telemedicine: A Discussion with FCC Commissioner Brendan Carr.” Additional information: https://bit.ly/2K6tK9G


Weekly Wrap-Up: Notable Health Care Developments From Last Week

 Administration –

  • On July 23, the Senate voted 86-9 to confirm Robert Wilkie as Secretary of the Department of Veterans Affairs. Press release: https://bit.ly/2Olz10m
  • On July 24, Department of Veterans Affairs (VA) announced that President Trump selected former VA White House Senior Advisor Thomas “Jake” Leinenkugel to lead the VA’s commission on mental health care programs. And on July 27, President Trump announced his intention to nominate James Gfrerer to be Assistant Secretary of the VA for Information and Technology. Press release: https://bit.ly/2LrMhTc VA Committee Press Release: http://bit.ly/2veXFXM
  • Also on July 24, CMS announced the addition of Paul Mango as the agency’s Chief Principal Deputy Administrator and Chief of Staff, as well as Chris Traylor as Deputy Administrator for Strategic Initiatives. In addition, Administrator Verma promoted Deputy Chief of Staff Brady Brookes to Deputy Administrator and Deputy Chief of Staff. Press release: https://go.cms.gov/2Oo2Mh0

 Legislative Activity –

  • On July 23, Rep. Sarbanes (D-MD) introduced the Biosimilars Competition Act of 2018 (H.R. 6478), which would require biologic and biosimilar drug manufactures to report anticompetitive agreements that keep lower-cost drugs off the market. Press release: https://bit.ly/2Oem1cU
  • On July 24, the House passed by a vote of 283-132 the Protect Medical Innovation Act of 2018 (H.R. 184), which would repeal the ACA’s medical device tax. The bill now moves to the Senate for consideration. Press release: http://bit.ly/2vd76a7 Bill text: https://bit.ly/2uXo24Y
  • Also on July 24, the House approved by voice vote the Improving Seniors Access to Quality Benefits Act (H.R. 4952), which would require the Secretary of HHS to conduct a study and submit a report on the effects of the inclusion of quality increases in the determination of blended benchmark amounts under part C of the Medicare program. The bill now moves to the Senate for consideration. Press release: http://bit.ly/2vd76a7
  • Also on July 24, Rep. DeSaulnier (D-CA) introduced the National Public Health Act (H.R. 6481), which would require the Department of Health and Human Services (HHS) and the National Academy of Medicine to establish and continuously update a list of public health crises. Press release: https://bit.ly/2mJYpjE
  • Also on July 24, Reps. Gabbard (D-HI) and Curbelo (R-FL) introduced the Marijuana Data Collection Act (H.R. 6495), which would create a federally-recognized report on state-level marijuana legalization policies and their effect on public health, safety, and the economy. Press release: https://bit.ly/2mE29mN
  • Also on July 24, Reps. Roe (R-TN) and Blumenauer (D-OR) introduced the Youth Mental Health Services Act (H.R. 6498), which would allow school districts to use Every Student Succeeds Act grant funding to implement community-based mental health services for students. Press release: https://bit.ly/2NN8rMu Text: https://bit.ly/2AbY4jg
  • On July 25, the House approved by a vote of 242-176 the Increasing Access to Lower Premium Plans and Expanding Health Savings Accounts Act of 2018 (H.R. 6311), which modify the definition of qualified health plan for purposes of the health insurance premium tax credit and to allow individuals purchasing health insurance in the individual market to purchase a lower premium copper plan. The House also approved by a vote of 277-142 the Restoring Access to Medication and Modernizing Health Savings Accounts Act of 2018 (H.R. 6199), which would include certain over the counter medical products as qualified medical expenses and make other changes to expand the use of HSAs. Both bills now move to the Senate for consideration. Press releases: http://bit.ly/2veUHTc and http://bit.ly/2vcOrv1 Bill texts: https://bit.ly/2LR8K8m and https://bit.ly/2uVfU5f
  • Also on July 25, the Senate HELP Committee approved the Patient Right to Know Drug Prices Act (S. 2554), which would end pharmacist gag clauses, by voice vote. Text: https://bit.ly/2LFLn4S
  • Also on July 25, Reps. Smith (R-NE), Black (R-TN), Crowley (D-NY), Griffith (R-VA), and Lujan (D-NM) introduced the Reducing Unnecessary Senior Hospitalization (RUSH) Act (H.R. 6502), which would establish a program to allow qualified group practices to furnish certain items and services at qualified skilled nursing facilities to individuals entitled to benefits under part A and enrolled under part B of the Medicare program. Press release: https://bit.ly/2LvedFC
  • Also on July 25, Rep. Doggett (D-TX) led a group of 81 Democratic colleagues in introducing H.R. 6505, which would allow the Secretary of HHS to negotiate prices of drugs furnished under Medicare Part D. Press release: https://bit.ly/2mP5GyN
  • Also on July 25, Reps. Kennedy (D-MA), Herrera Beutler (R-WA), Lujan (D-NM), and McKinley (R-WV) introduced the Accelerating Kids’ Access to Care Act (H.R. 6524), which would create an enhanced screening and enrollment process for Medicaid’s pediatric providers and suppliers when there is a low risk for fraud, waste, and abuse. Press release: https://bit.ly/2LJ6W4k Text: https://bit.ly/2NRl0q9
  • On July 26, Rep. Nolan (D-MN) introduced the Medicaid Estate Recovery Fairness Act (H.R. 6549), which would limit estate recovery under Medicaid with respect to newly eligible individuals. Press release: https://bit.ly/2mKr34i
  • Also on July 26, Reps. DeGette (D-CO), Speier (D-CA), McCaul (R-TX), Butterfield (D-NC), and Kelly (R-PA) introduced the Children’s Program of All-Inclusive Coordinated Care (ChiPACC) Act (H.R. 6560), which would provide states with the option to cover a children’s program of all-inclusive coordinated care under Medicaid. Press release: https://bit.ly/2mKKfP9
  • Also on July 26, House Energy & Commerce Ranking Member Pallone (D-NJ) and House Ways & Means Ranking Member Neal (D-MA) introduced Lower Out-of-Pocket Costs for Seniors Act (H.R. 6563), which would prevent growth rate cliff for out-of-pocket threshold under Medicare part D. Press release: https://bit.ly/2OnISCT
  • Also on July 26, Reps. Delaney (D-MD) and Budd (R-NC) introduced H.R. 6590, which would authorize a program on children and the media within the National Institute of Health to study the health and developmental effects of technology on infants, children, and adolescents. Press release: http://bit.ly/2ve5hJR
  • Also on July 26, Reps. McSally (R-AZ) and Cramer (R-ND) introduced H.R. 6608, which would provide for the development and dissemination of best practice guidelines for using data collected by prescription drug monitoring programs to identify drug diversion and abuse. Press release: http://bit.ly/2vjw5bY
  • Also on July 26, Sens. Cassidy (R-LA) and Hassan (D-NH) introduced the Substance Tableting and Encapsulating Enforcement and Registration (STEER) Act (S. 3281), which would amend the Controlled Substances Act to require a person that possesses or intends to possess a tableting machine or encapsulating machine to obtain registration from the Attorney General. Reps. Kustoff (R-TN) and Kuster (D-NH) introduced companion legislation in the House (H.R. 6554). Press release: http://bit.ly/2vcTg7D Bill text: http://bit.ly/2vh3jbB
  • Also on July 26, Sens. Coons (D-DE) and Gardner (R-CO) introduced the DEA Clearinghouse Act of 2018 (S. 3282), which would amend the Controlled Substances Act to require the order subject to review be submitted through a clearinghouse. Reps. Lance (R-NJ) and Matsui (D-CA) introduced companion legislation in the House (H.R. 6600). Press release: http://bit.ly/2ve4bOs Summary: http://bit.ly/2veBQYd

 ACA Implementation –

  • On July 24, CMS released a final rule that reissues, with additional explanation, the risk adjustment methodology that CMS previously established for transfers related to the 2017 benefit year. CMS also released guidance announcing that it would resume payments under the risk adjustment program, which had previously been halted due to ongoing litigation. Press release: https://go.cms.gov/2uPsClT Final rule: https://bit.ly/2vaAHAV Guidance: https://go.cms.gov/2LuWf6k
  • On July 26, the Attorneys General from 11 states and the District of Columbia filed a federal complaint challenging the Administration’s newly released final rules related to Association Health Plans. Complaint: https://on.ny.gov/2vfS43r
  • On July 27, CMS released a frequently asked questions documents on cost-sharing reduction discrepancies. FAQ: https://go.cms.gov/2OnF7gs
  • On July 29, CMS approved Wisconsin’s section 1332 waiver request, which would establish a reinsurance program in the state. Approval: https://go.cms.gov/2LB1Lo3


Medicare & Medicaid –

  • On July 25, CMS released a proposed rule making updates to the calendar year 2019 Medicare Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System. CMS also included requests for information on interoperability, price transparency, and how to best develop a model leveraging authority provided to the agency under the Medicare Part B Competitive Acquisition Program (CAP). Comments are due by September 24. Press release: https://go.cms.gov/2OnF30v Fact sheet: https://go.cms.gov/2LDdhP3 Proposed rule: http://bit.ly/2vagWJF
  • On July 26, U.S. Government Accountability Office (GAO) released a report recommending that improvements are needed to better oversee payment risks in Medicaid managed care. Summary: https://bit.ly/2LHptOt Report: https://bit.ly/2LGgsp6

Mental Health and Substance Use –

  • On July 25, HHS officials and the Federal Commission on School Safety (FCSS) held its second field visit at a middle school in Wisconsin to explore behavioral health integration in schools. Press release: https://bit.ly/2JXca7M
  • On July 26, Reps. Schiff (D-CA) led a group of 5 bipartisan members of Congress expressing support for the Compassionate Communication on HIPAA provisions included in the 21st Century Cures Act. Press release: http://bit.ly/2vfZrYs Letter: http://bit.ly/2vf15JZ

Drug Prices and Regulation

  • On July 23, HHS released an analysis of the potential savings using full generic substitution of multiple source brand drugs in Medicare Part D, finding that if all brand name drugs with a generic available were substituted with generics, the Part D program and beneficiaries would have saved almost $3 billion in 2016. Analysis: https://bit.ly/2LrnKgr
  • Also on July 23, Food and Drug Administration (FDA) announced that it is continuing to take key actions on bulk drug substances used for compounding to advance the regulatory framework governing compounded drugs and to protect patients. Press release: https://bit.ly/2mGt41h
  • On July 25, FDA issued a request for comments on facilitating competition and innovation in the biological products marketplace. Comments are due by September 21. Document: https://bit.ly/2mOh4uR
  • On July 27, FDA released Generic Drug User Fee Rates for FY19. Notice: https://bit.ly/2mP5orq
  • Also on July 27, House Energy & Commerce Committee Chair Walden (R-OR) Subcommittee on Oversight Chair Harper (R-MS), and Subcommittee on Health Chair Burgess (R-TX) sent a letter to the Federal Trade Commission requesting that they conduct a retrospective review of Pharmacy Benefit Manager mergers, and how these mergers have affected prices for consumers. Press release: http://bit.ly/2vb8b2e Letter: http://bit.ly/2viZZx1

Military & Veterans’ Health –

  • Also on July 24, GAO released a report describing the progress VA has made on its plan for changing the appeals process for veterans disability claim decisions. Summary with link to report: http://bit.ly/2LtpZjS
  • On July 25, Senate Veterans Affairs Committee Ranking Member Tester (D-MT) led a group of 7 democrats in a letter to VA Inspector General Missal requesting an investigation into political interference in the VA’s transparency processes. Press release: http://bit.ly/2Ojo2Eu Letter: http://bit.ly/2OpKAmW


  • On July 24, HHS released the 2017 Annual Report of HHS Projects to Build Data Capacity for Patient-Centered Outcomes Research, which describes the 21 projects that were active in 2017. Report: https://bit.ly/2LTLxTb
  • On July 27, Centers for Disease Control and Prevention (CDC) released a report on the application of the Million Hearts Hypertension Prevalence Estimator Tool in 2016. Report: https://bit.ly/2v6TDQU
  • Also on July 27, Senate HELP Committee Ranking Member Murray (D-WA) sent a letter to HHS Secretary Azar expressing concern about the Department’s efforts to address the long-term emotional, behavioral, and physical impact of President Trump’s family separation policy on children separated from their parents at the border. Press release: http://bit.ly/2ve03xW Letter: http://bit.ly/2vg86dH